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A multi-center, open, randomized, 18-month, parallel-group, superiority study to compare the effect of proactive therapeutic drug monitoring versus standard of care with regards to maintenance of sustained disease control without flare in adults with rheumatoid arthritis treated with a subcutaneous tumor necrosis factor inhibitor

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510184-35-00
Enrollment
410
Registered
2024-05-21
Start date
2024-08-20
Completion date
Unknown
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Brief summary

Sustained disease control over the follow-up period of 18 months without flare, with flare defined as either of the following: A combination of an increase in Disease Activity Score using 28 joints- C-reactive protein (DAS28-CRP) ≥ 1.2, or ≥ 0.6 if DAS28-CRP ≥ 3.2, AND  2 swollen joints on examination of 44 joints Consensus between participant and physician that disease flare has occurred, leading to a major change in treatment

Detailed description

Disease activity at 4, 8, 12, and 18 months, Time to disease flare, Number and type of adverse events (AE), Drug survival, drug consumption, occurrence of ADAb, serum drug levels

Interventions

DRUGAMGEVITA 40 mg solution for injection in pre-filled syringe
DRUGHyrimoz 40 mg solution for injection in pre-filled syringe
DRUGIdacio 40 mg solution for injection in pre-filled pen
DRUGImraldi 40 mg solution for injection in pre-filled pen
DRUGHumira 40 mg solution for injection in pre-filled syringe
DRUGYuflyma 40 mg solution for injection in pre-filled syringe
DRUGHefiya 40 mg solution for injection in pre-filled syringe
DRUGHumira 40 mg solution for injection in pre-filled pen
DRUGAMGEVITA 40 mg solution for injection in pre-filled pen
DRUGIdacio 40 mg solution for injection in pre-filled syringe
DRUGHyrimoz 40 mg solution for injection in pre-filled pen
DRUGHukyndra 40 mg solution for injection in pre-filled syringe
DRUGYuflyma 40 mg solution for injection in pre-filled pen
DRUGHulio 40 mg solution for injection in pre-filled pen
DRUGLibmyris 40 mg solution for injection in pre-filled pen
DRUGHefiya 40 mg solution for injection in pre-filled pen
DRUGHukyndra 40 mg solution for injection in pre-filled pen
DRUGImraldi 40 mg solution for injection in pre-filled syringe
DRUGHulio 40 mg solution for injection in pre-filled syringe

Sponsors

Diakonhjemmet Sykehus AS, University Of Medicine And Pharmacy Carol Davila Bucharest, Medical University Of Vienna, Karolinska University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Sustained disease control over the follow-up period of 18 months without flare, with flare defined as either of the following: A combination of an increase in Disease Activity Score using 28 joints- C-reactive protein (DAS28-CRP) ≥ 1.2, or ≥ 0.6 if DAS28-CRP ≥ 3.2, AND  2 swollen joints on examination of 44 joints Consensus between participant and physician that disease flare has occurred, leading to a major change in treatment—

Secondary

MeasureTime frame
Disease activity at 4, 8, 12, and 18 months, Time to disease flare, Number and type of adverse events (AE), Drug survival, drug consumption, occurrence of ADAb, serum drug levels—

Countries

Austria, Italy, Norway, Romania, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026